CHEMISTRY CALIBRATOR

K020454 · Jas Diagnostics, Inc. · JIT · Apr 8, 2002 · Clinical Chemistry

Device Facts

• Record ID: K020454
• Device Name: CHEMISTRY CALIBRATOR
• Applicant: Jas Diagnostics, Inc.
• Product Code: JIT · Clinical Chemistry
• Decision Date: Apr 8, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

Intended for the calibration of multiple in vitro quantitative chemistry assays on automated chemistry analyzers, such as the Roche Cobas Mira Chemistry Analyzers. "A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens."

Device Story

JAS Chemistry Calibrator is an in vitro diagnostic device used to calibrate automated chemistry analyzers (e.g., Roche Cobas Mira). It establishes reference points for quantitative assays, enabling accurate measurement of substances in human specimens. Used in clinical laboratory settings by trained laboratory personnel. The calibrator ensures the accuracy and reliability of patient test results by standardizing the analyzer's response. It does not perform analysis itself but serves as a reference material for the analytical system.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

In vitro diagnostic calibrator; liquid or lyophilized chemical preparation; designed for use with automated chemistry analyzers; non-sterile; no software or electronic components.

Indications for Use

Indicated for use as a calibrator in in vitro quantitative chemistry assays on automated chemistry analyzers to establish reference points for measuring substances in human specimens.

Regulatory Classification

Identification

A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Reference Devices

• Roche Cobas Mira Chemistry Analyzers

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" around the perimeter. Inside the circle is a stylized image of three human figures, one behind the other, with their arms raised.

Food and 'Drug Administration

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

APR = 8 2002

Mr. David Johnston Technical Director JAS Diagnostics, Inc. 7220 N.W. 58th Street Miami, FL 33166

Re: k020454

Trade/Device Name: JAS Chemistry Calibrator Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT Dated: January 24, 2002 Received: February 11, 2002

Dear Mr. Johnston:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 .

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, ( Jease contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrb/dsma/dsmamain.html".

Sincerely yours,

Steven Butman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): N/A Device Name: 45 CHEMISTRY CALIBRATOR Indications for Use:

Intended for the calibration of multiple in vitro quantitative chemistry assays on automated chemistry analyzers, such as the Roche Cobas Mira Chemistry Analyzers. "A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens."

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Clinical Laboratory Devices

Division of Clinical Laboratory
510(k) Number K00205

ﺎ ﮨﮯ Prescription Use

OR

Over-The-Counter Use

(Per 21 CFR 801.109)

(Optional Format 1-2-96)